- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02204605
Video-based Consensus Opinion for Hand and Upper Extremity Problems
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Before visiting a specialist, patients have assumptions regarding diagnosis, etiology, prognosis, and preferred treatment for their condition. Naturally, some of these assumptions may be inaccurate or incomplete or there may be room for debate and disagreement even among specialists. We are looking for ways to make unexpected and indeterminate aspects of an illness less unsettling for patients. When the hand surgeon's advice doesn't ring true, the patient may lose confidence in that provider. Sometimes the interaction can feel disrespectful and even adversarial. We are curious whether patient's satisfaction with diagnosis, surgeon, and treatment plan would improve if they were able to get an opinion from many surgeons at once. One feasible way to do that would be to show an edited and anonymized video to a set of hand surgeons for their opinions on diagnosis and treatment.
Primary study question:
Among patients with initially puzzling pains, there is no difference in satisfaction with diagnosis between patients that receive a video based consensus opinion and those that receive routine care from a single hand surgeon controlling for psychological factors, demographics, and initial and final diagnosis.
Secondary study questions:
- Among patients with initially puzzling pains, there is no difference in pain intensity and disability one month after the initial visit between patient that receive a consensus diagnosis and those that receive routine care from a single surgeon.
- There is no variation in diagnosis between observers (Observers are hand surgeons viewing the visit video and consulting on the diagnosis).
Studietype
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- All patients (>18 years) presenting to Dr. David Ring with painful conditions that are puzzling (A puzzling pain condition is defined as Dr. Ring being puzzled about what is causing the pain. Subject eligibility based on this criterion will be determined by Dr. Ring).
- English fluency and literacy
- Able to provide informed consent
Exclusion Criteria:
- Pregnant Women
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Control
Visits are not videotaped
|
|
|
Eksperimentell: Videoed Patients
Patients will have their visit videotaped.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Likert Scale for Satisfaction
Tidsramme: At enrollment
|
At enrollment
|
|
Likert Scale for Satisfaction
Tidsramme: 4-6 weeks
|
4-6 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Patient Self-Efficacy Questionnaire (PSEQ-2)
Tidsramme: At enrollment
|
At enrollment
|
|
Patient Self-Efficacy Questionnaire (PSEQ-2)
Tidsramme: 4-6 weeks
|
4-6 weeks
|
|
Patient Health Questionnaire (PHQ-2)
Tidsramme: at enrollment
|
at enrollment
|
|
Patient Health Questionnaire (PHQ-2)
Tidsramme: 4-6 weeks
|
4-6 weeks
|
|
QuickDASH (Disabilities of the Arm, Shoulder, and Hand)
Tidsramme: At enrollment
|
At enrollment
|
|
QuickDASH (Disabilities of the Arm, Shoulder, and Hand)
Tidsramme: 4-6 weeks
|
4-6 weeks
|
|
Numerical Rating Scale for Pain
Tidsramme: at enrollment
|
at enrollment
|
|
Numerical Rating Scale for Pain
Tidsramme: 4-6 weeks
|
4-6 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .